WallFlex™ Duodenal M00565010Recalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 08714729456483), received between Feb 1, 2017 and Aug 14, 2026 — classified as 1 death, 12 injuries, 17 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (8 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 30 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 14, 2026Deformation Due to Compressive Stress; Material Deformation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50261972 ↗
• MalfunctionJul 28, 2026Difficult or Delayed Positioning; Use of Device Problem; Activation, Positioning or Separation Problem; Positioning Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50063589 ↗
• MalfunctionSep 30, 2024Premature Activation; Material Deformation; Premature Activation; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ENTERAL DUODENAL STENT WAS TO BE USED DURING A STENT PLACEMENT PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING PREPARATION, WHEN OPENING THE PACKAGE, IT WAS NOTED THAT THE STENT HAD ALREADY DEPLOYED. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20334687 ↗
• DeathJul 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED, TO BOSTON SCIENTIFIC CORPORATION. THAT A WALLFLEX ENTERAL DUODENAL STENT WAS IMPLANTED IN THE DUODENUM TO TREAT A MALIGNANT GASTRODUODENAL STRICTURE, DURING A PALLIATIVE ENDOSCOPIC STENT TREATMENT PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE PATIENT SUFFERED A PERFORATION. WHICH WAS CONFIRMED, UNDER KIDNEY, URETER AND BLADDER X-RAY (KUB). ON (B)(6) 2024, THE PATIENT PASSED AWAY. IN THE PHYSICIAN'S ASSESSMENT, THE CAUSE OF THE PATIENT'S DEATH WAS THE PERFORATION.

  Patient problems: Perforation

  MAUDE report 19652154 ↗
• MalfunctionJun 5, 2024Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX DUODENAL STENT WAS TO BE IMPLANTED DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2024. IT WAS REPORTED THAT THE STENT WAS TORN. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19472164 ↗
• InjuryJun 4, 2024Material Deformation; Activation Failure; Material Deformation; Activation Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ENTERAL DUODENAL STENT WAS IMPLANTED TO TREAT A MALIGNANT STENOSIS IN THE DUODENAL BULB DESCENDING CONJUNCTION DURING AN INTESTINAL METAL STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2024. THE PATIENT'S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE STENT WAS DEPLOYED; HOWEVER, THE STENT DID NOT EXPAND, AND THE TIP PORTION OF THE STENT WAS LOOSE. THE STENT WAS REMOVED FROM THE PATIENT USING SNARES. ANOTHER WALLFLEX ENTERAL DUODENAL STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19463895 ↗
• MalfunctionMay 22, 2024Material Deformation; Positioning Problem; Material Deformation; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX DUODENAL STENT WAS IMPLANTED DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2024. THE PATIENT'S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE STENT COULD NOT BE POSITIONED CORRECTLY DUE TO STENT DEFORMATION. THE STENT REMAINS IMPLANTED, AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19377624 ↗
• MalfunctionApr 9, 2024Difficult to Remove; Difficult to Remove

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX DUODENAL STENT WAS TO BE IMPLANTED IN THE DUODENUM TO TREAT AN APPROXIMATE 3CM MALIGNANT DUODENAL STRICTURE DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2024. THE PATIENT'S ANATOMY WAS NOT TORTUOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE STENT WAS ABLE TO BE DEPLOYED. HOWEVER, WHEN THE DELIVERY SYSTEM WAS ATTEMPTED TO BE REMOVED, THE STENT GOT CAUGHT ON THE CATHETER. THE STENT WAS THEN REMOVED TOGETHER WITH THE DELIVERY SYSTEM, AND ANOTHER WALLFLEX DUODENAL STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19076046 ↗
• InjuryMar 22, 2024Use of Device Problem; Device Stenosis; Use of Device Problem; Device Stenosis

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ENTERAL DUODENAL STENT WAS IMPLANTED IN THE PYLORIC CHANNEL AND DUODENAL BULB TO TREAT A BENIGN GASTRODUODENAL STRICTURE DURING AN UPPER GASTROINTESTINAL (GI) ENDOSCOPY WITH A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2023. THE PATIENT'S ANATOMY WAS TORTUOUS. THE PATIENT HAD TWO PREVIOUSLY IMPLANTED BOSTON SCIENTIFIC PLASTIC STENTS WHICH WERE SCHEDULED FOR EVALUATION AND REMOVAL ON (B)(6) 2024. DURING THE ROUTINE FOLLOW-UP PROCEDURE, STENT INGROWTH WAS NOTED ON THE WALLFLEX ENTERAL STENT. CONSEQUENTLY, A RADIOFREQUENCY ABLATION PROCEDURE WAS PERFORMED USING A HABIB DEVICE TO GET RID OF THE INGROWTH. THE STENT REMAINED IMPLANTED, AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: IT WAS REPORTED THAT THE WALLFLEX ENTERAL STENT WAS IMPLANTED TO TREAT A BENIGN GASTRODUODENAL STRICTURE. HOWEVER, PER THE WALLFLEX DUODENAL STENT SYSTEM WITH ANCHOR LOCK DELIVERY SYSTEM INSTRUCTIONS FOR USE (IFU), THE DEVICE IS INDICATED FOR THE PALLIATIVE TREATMENT OF GASTRODUODENAL OBSTRUCTIONS PRODUCED BY MALIGNANT NEOPLASMS. THE DEVICE IS NOT INDICATED TO BE PLACED FOR THE TR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18961145 ↗
• InjuryOct 11, 2023Material Deformation; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ENTERAL DUODENAL STENT WAS TO BE IMPLANTED IN THE DUODENUM TO TREAT A 2CM MALIGNANT TUMOR DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2023. THE PATIENT'S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE STENT WAS DEPLOYED; HOWEVER, IT WAS NOTICED THAT THE STENT WAS KINKED. SUBSEQUENTLY, THE STENT WAS REMOVED USING FOREIGN BODY FORCEPS. THE PROCEDURE WAS COMPLETED WITH ANOTHER WALLFLEX ENTERAL DUODENAL STENT. IN ADDITION, IT WAS NOTED THAT ACTION TAKEN BY THE PHYSICIAN TO RESOLVE THE EVENT ALSO INCLUDED OBSERVATION. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17912479 ↗
• MalfunctionJul 28, 2022Premature Activation; Difficult to Advance; Premature Activation; Difficult to Advance

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON JULY 13, 2022 THAT A WALLFLEX DUODENAL STENT WAS TO BE IMPLANTED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, THE WALLFLEX DUODENAL STENT LOOKED NORMAL WHEN IT WAS LOADED OVER THE GUIDEWIRE AND WHEN THE WALLFLEX DUODENAL STENT WAS DEPLOYED INSIDE THE PATIENT. AFTER REMOVAL OF THE WALLFLEX DUODENAL STENT DELIVERY SYSTEM, AN X-RAY WAS TAKEN AND THE WALLFLEX DUODENAL STENT WAS NOT PRESENT INSIDE THE PATIENT. THE WALLFLEX DUODENAL STENT WAS FOUND ON THE PROCEDURE ROOM FLOOR. A SECOND ATTEMPT WAS MADE, BUT THE WIRE WAS UNABLE TO BE ADVANCED. THE PROCEDURE WAS COMPLETED WITH ANOTHER WALLFLEX DUODENAL STENT. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT CONDITION AFTER THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15124751 ↗
• InjuryMay 27, 2022Premature Activation; Difficult to Remove; Activation Failure; Premature Activation; Difficult to Remove; Activation Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON MAY 04, 2022 THAT A WALLFLEX DUODENAL STENT WAS TO BE IMPLANTED DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, THE STENT DEPLOYED PREMATURELY BEFORE REACHING THE RECONSTRAINMENT LIMIT MARK. THE STENT COILED ON ITSELF AND WAS DEPLOYED NOT IN THE INTENDED ANATOMY. THE STENT WAS REMOVED FROM THE PATIENT WITH DIFFICULTY DUE TO INCORRECT PLACEMENT AND ANOTHER WALLFLEX DUODENAL STENT WAS IMPLANTED TO COMPLETE THE PROCEDURE. THERE ARE NO KNOWN PATIENT COMPLICATIONS DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14522048 ↗
• InjuryMay 20, 2022Premature Activation; Premature Activation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2022 THAT A WALLFLEX DUODENAL STENT WAS IMPLANTED TO TREAT A MALIGNANT STRICTURE IN THE ASCENDING PART OF THE DUODENUM DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2022. THE PATIENT'S ANATOMY WAS NOTED TO BE TORTUOUS/TIGHT AND WAS ACCESSED USING A PEDIATRIC COLONOSCOPE. DURING THE PROCEDURE, THE STENT DEPLOYED PREMATURELY AT AN INCORRECT LOCATION. THE PHYSICIAN RE-POSITIONED THE STENT INTO THE CORRECT LOCATION WITH THE USE OF FORCEPS. THE WALLFLEX DUODENAL STENT REMAINS IMPLANTED AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14455134 ↗
• MalfunctionMay 4, 2022Material Deformation; Activation Problem

  WHEN DEPLOYING STENT IN DUODENUM, STENT DEPLOYED TOO SOON (BEFORE THE POINT OF NO RETURN). DUE TO STENT DEPLOYING SO SOON IT COILED ON ITSELF AND DID NOT DEPLOY AS INTENDED. STENT WAS THEN HARD TO REMOVE DUE TO DEPLOYING INCORRECTLY.

  Patient problems: Insufficient Information

  MAUDE report 14280109 ↗
• InjuryJul 19, 2021Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON JUNE 26, 2021 THAT A WALLFLEX DUODENAL STENT WAS IMPLANTED DURING A STENT PLACEMENT PROCEDURE PERFORMED ON AN UNKNOWN DATE. ON AN UNKNOWN DATE, DURING ROUTINE FOLLOW-UP, IT WAS NOTED THAT THE STENT WAS BROKEN INTO THREE PIECES AND WAS SEPARATED. ANOTHER WALLFLEX DUODENAL STENT WAS IMPLANTED AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED ON JULY 26, 2021. A HANAROSTENT DUODENUM STENT WAS IMPLANTED ON (B)(6) 2021. ON (B)(6) 2021, THE PATIENT PRESENTED WITH VOMITING, A COMPUTED TOMOGRAPHY (CT) SCAN WAS PERFORMED AND IT WAS NOTED THAT THE STENT WAS BROKEN. ANOTHER HANAROSTENT WAS IMPLANTED STENT-IN-STENT ON (B)(6) 2021.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Vomiting

  MAUDE report 12191670 ↗
• InjuryFeb 26, 2021Material Deformation; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2021 THAT A WALLFLEX DUODENAL STENT WAS TO BE IMPLANTED TO TREAT A DUODENAL OBSTRUCTION DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, THE STENT WAS ABLE TO BE DEPLOYED; HOWEVER, IT WAS NOTED THAT THE STENT BECAME UNRAVELED. THE STENT WAS REMOVED USING GRASPER FORCEP. THE PROCEDURE WAS COMPLETED WITH ANOTHER WALLFLEX DUODENAL STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11385878 ↗
• InjuryJan 14, 2021Material Deformation; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX DUODENAL STENT WAS TO BE IMPLANTED TO TREAT A GASTRIC OUTLET OBSTRUCTION IN THE DUODENUM DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2020. REPORTEDLY, THE PATIENT'S ANATOMY WAS NOT TORTUOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN THE PHYSICIAN ATTEMPTED TO DEPLOY THE STENT, THE STENT DID NOT DEPLOY AS IT NORMALLY WOULD AND BEGAN TO UNRAVEL. THE PHYSICIAN TRIED TO RECONSTRAIN THE STENT BUT IT WAS UNSUCCESSFUL. REPORTEDLY, THE STENT WAS REMOVED FROM THE PATIENT PARTIALLY DEPLOYED ON THE DELIVERY SYSTEM AND ANOTHER WALLFLEX DUODENAL STENT WAS IMPLANTED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. NOTE: THIS EVENT HAS BEEN DEEMED A MDR-REPORTABLE EVENT BASED ON INVESTIGATION RESULTS WHICH REVEALED THAT THE STENT WAS DEFORMED AND DAMAGED. ADDITIONAL INFORMATION WAS RECEIVED FROM THE COMPLAINANT ON JANUARY 08, 2021, REPORTING THAT THE STENT BEGAN TO "UNRAVEL" WHEN ATTEMPTED TO DEPLOY THE STENT. THE STENT WAS THEN FULLY DEPLOYED INSIDE THE PATIENT'S DUODENUM BECAUSE IT

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11174434 ↗
• MalfunctionJan 4, 2021Premature Activation; Premature Activation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2020 THAT A WALLFLEX DUODENAL STENT WAS TO BE IMPLANTED TO TREAT AN APPROXIMATELY 10 CM PANCREATIC CANCER STRICTURE IN THE DUODENUM DURING A DUODENAL STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2020. REPORTEDLY, THE PATIENT'S ANATOMY WAS TORTUOUS AND WAS DILATED PRIOR TO STENT PLACEMENT. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE PHYSICIAN BELIEVED THAT THE STENT WAS DEPLOYED CORRECTLY INSIDE THE PATIENT. HOWEVER, WHEN THE SCOPE WAS PULLED OUT FROM THE PATIENT, THE STENT WAS DEPLOYED INSIDE THE SCOPE. REPORTEDLY, THE PROCEDURE WAS CANCELLED AND RESCHEDULED ON (B)(6) 2020 AS ANOTHER STENT WAS NOT AVAILABLE ON-SITE THE DAY OF THE ORIGINAL PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11111921 ↗
• MalfunctionJan 7, 2019Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2018 THAT A WALLFLEX DUODENAL STENT WAS TO BE USED TO TREAT A SHORT AND MALIGNANT DUODENAL NEOPLASTIC STENOSIS DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2018. REPORTEDLY, THE PATIENT'S ANATOMY WAS TORTUOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE DELIVERY SYSTEM BROKE DISTAL TO THE STENT, BEFORE THE STENT WAS RELEASED. THE DEVICE WAS REMOVED AND ANOTHER WALLFLEX DUODENAL STENT WAS IMPLANTED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATION REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8223949 ↗
• MalfunctionNov 19, 2018Positioning Problem; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON NOVEMBER 5, 2018 THAT A WALLFLEX DUODENAL STENT HAS BEEN IMPLANTED TO TREAT A MALIGNANT STRICTURE IN THE DUODENUM DURING A PROCEDURE PERFORMED ON (B)(6) 2018. REPORTEDLY, THE PATIENT'S ANATOMY WAS NOT DILATED PRIOR TO STENT PLACEMENT. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE STENT WAS INTENTIONALLY RELEASED, BUT WAS DEPLOYED DISTALLY FROM THE TARGET LOCATION. REPORTEDLY, THE STENT REMAINS IMPLANTED AND A DIFFERENT STENT WAS PLACED PROXIMALLY TO COVER THE ENTIRE STRICTURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8087162 ↗
• InjuryAug 15, 2018Difficult or Delayed Positioning; Positioning Problem; Difficult or Delayed Positioning; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2018 THAT A WALLFLEX DUODENAL STENT HAS BEEN IMPLANTED TO TREAT A 3/4 CM MALIGNANT STRICTURE IN THE DUODENUM DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2018. REPORTEDLY, THE PATIENT'S ANATOMY WAS NOT TORTUOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. ACCORDING TO THE COMPLAINANT, DURING PROCEDURE, THE STENT WAS ATTEMPTED TO BE DEPLOYED, HOWEVER, THERE WAS DIFFICULTY FULLY DEPLOYING THE STENT. WHEN THE OUTER SHEATH WAS MANUALLY PULLED AND THE STENT WAS DEPLOYED BUT WAS NOT IN THE TARGET LOCATION. REPORTEDLY, THE PHYSICIAN LEFT THE STENT IN PLACE AND A LARGER DUODENAL STENT (9 CM) WAS IMPLANTED TO COMPLETE THE PROCEDURE. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7785591 ↗
• MalfunctionJul 30, 2018Premature Activation; Premature Activation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2018 THAT A WALLFLEX DUODENAL STENT WAS TO BE USED TO TREAT MALIGNANT STRICTURE IN THE PYLORUS DUE TO ANTRAL GASTRIC CANCER DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2018. REPORTEDLY, THE PATIENT'S ANATOMY WAS NOT TORTUOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. ACCORDING TO THE COMPLAINANT, DURING PROCEDURE, THE STENT WAS ATTEMPTED TO BE DEPLOYED; HOWEVER, IT WAS NOTED THAT THE DELIVERY SYSTEM DID NOT CONTAIN THE STENT AFTER FULL DEPLOYMENT. THE DELIVERY SYSTEM WAS REMOVED FROM THE PATIENT, AND ANOTHER WALLFLEX DUODENAL STENT WAS PLACED TO COMPLETE THE PROCEDURE. REPORTEDLY, THE DEVICE WAS INSPECTED AND FOUND NO STENT ON THE DELIVERY SYSTEM; HOWEVER, A STENT WAS FOUND ON THE GROUND. ACCORDING TO THE COMPLAINANT, THE STENT AND DELIVERY SYSTEM WERE SEPARATED IN THE PACKAGE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7732861 ↗
• MalfunctionMay 3, 2018Premature Activation; Premature Activation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON APRIL 10, 2018 THAT A WALLFLEX DUODENAL STENT WAS TO BE USED DURING A STENT PLACEMENT PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING PROCEDURE, THE GUIDEWIRE WAS IMPOSSIBLE TO INTRODUCE THROUGH THE WALLFLEX DELIVERY SYSTEM. OUTSIDE OF THE PATIENT, THE GUIDEWIRE WAS STUCK IN THE WALLFLEX DELIVERY SYSTEM AND WHILE TRYING TO REMOVE IT THE STENT DEPLOYED. THE PROCEDURE WAS COMPLETED WITH ANOTHER STENT WITHOUT ISSUE. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7485456 ↗
• MalfunctionFeb 28, 2018Premature Activation; Premature Activation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2018 THAT A WALLFLEX ENTERAL DUODENAL STENT WAS TO BE USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH DUODENAL STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2016. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE STENT WAS PREMATURELY DEPLOYED OUTSIDE THE SCOPE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT SIZE OF WALLFLEX ENTERAL DUODENAL STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7302757 ↗
• InjuryJan 2, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2017 THAT A WALLFLEX DUODENAL STENT WAS IMPLANTED TO TREAT A MALIGNANT STRICTURE DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2017. REPORTEDLY, THE PATIENT¿S ANATOMY WAS NOT DILATED PRIOR TO STENT PLACEMENT. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE PHYSICIAN WAS ABLE TO DEPLOY THE STENT, HOWEVER, AN EXTRA 6¿ LONG WIRE WAS NOTED TO HAVE FALLEN INSIDE THE PATIENT. THE PHYSICIAN STATED THERE WAS A SMALL TUG DURING DEPLOYMENT BUT NOT WHAT HE WOULD EXPECT WOULD BREAK A WIRE. IT IS UNKNOWN IF THE WIRE CAME OFF THE STENT OR OUT OF THE DELIVERY SYSTEM. REPORTEDLY, IT WAS CONFIRMED THAT THE DUODENAL STENT AND THE DELIVERY SYSTEM APPEARED INTACT AND NOT VISIBLY DAMAGED OR BROKEN. THE STENT REMAINS IMPLANTED AND THE DETACHED WIRE WAS RETRIEVED FROM THE PATIENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT¿S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7157753 ↗